A few weeks ago Teva and Lonza pulled back from the race to introduce a biosimilar version of rituximab, and now Samsung and BiogenIdec have pulled up lame. Both companies through unnamed sources indicated the decisions were made due to an uncertain regulatory environment. Seems odd to me, nothing particularly surprising came out of the FDA guidelines issued in the US and I can't think of any other major area of the world that threw up a road block suddenly.
Samsung halts biosimilar rituximab trial on regulatory concerns.
Apparently, according to the In-pharma Technologist post above, that leaves Boehringer Ingelheim as the only major declared competitor still in the running. This bears some watching.
Posted by Bruce Lehr Oct 18th 2012.
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